A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
研究概览
简要总结
This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines
详细描述
There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.
- •Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
- •Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
- •Positive response (i.e. development of symptoms) to provocation test on day of randomization
- •Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
- •Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
- •Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules
排除标准
- •History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
- •Participants who have concomitant CSU at screening
- •Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
- •Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
- •Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
- •Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
- •Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies
研究组 & 干预措施
Placebo SC q4w, cholinergic urticaria
Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria
干预措施: Placebo (Other)
Ligelizumab low dose, symptomatic dermographism group
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
干预措施: Ligelizumab (Drug)
Ligelizumab high dose, symptomatic dermographism
Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
干预措施: Ligelizumab (Drug)
Placebo SC q4W, symptomatic dermographism
Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism
干预措施: Placebo (Other)
Ligelizumab low dose, cold urticaria
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria
干预措施: Ligelizumab (Drug)
Ligelizumab high dose, cold urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria
干预措施: Ligelizumab (Drug)
Placebo SC q4w, cold urticaria
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
干预措施: Placebo (Other)
Ligelizumab high dose, cholinergic urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria
干预措施: Ligelizumab (Drug)
结局指标
主要结局
Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
时间窗: Baseline, Week 12
Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed
Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria
时间窗: Baseline, Week 12
Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")
Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria
时间窗: Baseline, Week 12
The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.
次要结局
- Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest(Baseline, Week 12)
- Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism(Baseline, Week 12)
- Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0(Week 12)
- Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0(Week 12)
- Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria(Baseline, Week 12)
- Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0(Week 12)